Director, Regulatory Affairs CMC Outsourcing

  • Company: Merck
  • Location: West Point, Pennsylvania
  • Posted: November 12, 2016
  • Reference ID: REG002651
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

As Director of CMC Outsourcing Strategy, this position will develop and implement the strategy and operational model for flexible resourcing of select CMC Regulatory activities, with an ultimate goal to expand the capability and flexibility of global CMC resources across the small molecules, biologics, and vaccines portfolios.

This position will be responsible for directing the activities in support of our current (and future) outsourced scope of work. Responsibilities will include managing processes and connections between the external partner and the various stakeholders within CMC to ensure that we are efficiently and effectively delivering high quality CMC submissions, on time globally. Additionally, the incumbent will need to have a close working relationship with Procurement and the extended team within Global Regulatory Affairs as part of effective execution of the sourcing management process.

The incumbent will require a working knowledge of and skills in CMC, experience in outsourcing, and project and change management with a strong track record of demonstrated leadership and capability to foster collaborative relationships.

Primary Responsibilities:

  • Build and manage the processes and facilitate the network of resources to support one or more vendor partner team to facilitate execution on our sourced scope of work.
  • Manage the CMC books of business and schedules of sourced activities to support efficient, on-time execution of high-quality CMC submissions. Negotiate and communicate priorities to ensure delivery of the right work at the right time.
  • Coordinate and conduct reviews of vendor deliverables in accordance with established practices, as needed.
  • Establish and manage the relationships between Merck and external partners to deliver on business commitments.
  • Actively facilitate (and escalate as necessary) resolution of process and work plan issues related to enable delivery of high-quality, on-time materials.
  • Collaborating with internal teams and external parties to ensure best possible delivery of sourced submission work through clearly defined objectives and actively managing and tracking overall performance (via metrics) of assigned vendor(s).
  • Monitor quality of CMC deliverables and provide regular reports to management on the performance of vendors, ensuring quality, regulatory conformance and timing deliverables are met.
  • Provide regular feedback to vendor management and internal teams to manage and rectify performance issues
  • Actively collaborate with and provide guidance to vendors to assure new capabilities and services are developed and existing capabilities and processes are assessed and improved (on an ongoing basis), and assuring consistent application of roles and processes across projects.
  • Facilitate the collection and development of business requirements (i.e. resource estimates, processes, SOPS, etc.) with the cross-functional regulatory team and external business partners in support of the RPI and RFP processes.
  • Manage communication and change management within the internal organization.
  • Support of annual business planning and the analysis of the annual financial plan related to external partner expenditures.


Bachelor's degree in science-related discipline

Knowledge of regulations related to CMC experience with developing strategy and execution of post approval CMC changes
Proficiency in CMC knowledge for pharmaceutical products, vaccines and/or biologic products.
Strong experience with leading successful delivery of projects (pipeline, business improvement, and/or change management projects)
Strong negotiation, interpersonal, written/oral communication, leadership skills and fluent in English language
Ability to lead by influence and work effectively in matrix organizational structures
Expert at motivating individuals, teams to manage the change aspects of implementing a new, outsourced model.
At least 10 years of relevant pharmaceutical industry that includes working with external partners.

Demonstrated experience driving change initiative projects
Advanced Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at

Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster
EEOC GINA Supplement​

Share this Job